The following data is part of a premarket notification filed by Action Eyewear Corp. with the FDA for Action Medtek/dentek Eyeglasses.
| Device ID | K925564 |
| 510k Number | K925564 |
| Device Name: | ACTION MEDTEK/DENTEK EYEGLASSES |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | ACTION EYEWEAR CORP. 1401 DUFF DRIVE, UNIT 100 Fort Collin, CO 80524 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-03 |
| Decision Date | 1993-10-07 |